FDA Hearing Explores Competition & Innovation in Biosimilars
When it comes to how to increase the development and utilization of biosimilars, the Food and Drug Administration is all ears. On Tuesday, the agency welcomed numerous physicians and experts to testify on competition and innovation in the biosimilars marketplace. And at least one physician identified a critical component in uptake: physician confidence.
Patents, Progress & Patient Access
Could a recent memorandum from the U.S. Patent and Trademark Office impact treatment options for patients? Washington, DC’s nonprofit Bipartisan Policy Center says: Yes.
Mapping Report Reveals Access Disparities among European Patients
How accessible is your health care? It all depends upon where you live, as a new report from the European Federation of Crohn’s & Ulcerative Colitis Associations confirms.
Labeling Debate Hones in on Biosimilarity Statement
Stakeholders are divided over a provision of the Food and Drug Administration’s draft regulatory guidance on biosimilar labeling, letters to the FDA reveal.
FDA Advisory Committee’s Infliximab Vote Raises Patient Safety Concerns
The Food and Drug Administration could soon approve a complex biosimilar to treat eight disease states and patient groups – even though clinical testing data has been submitted for only two.
